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Substances of Very High Concern - what you need to know

What are SVHCs?

In general terms, an SVHC is a substance meeting one or more of the following criteria:

Class 1 or 2 carcinogen, mutagen, or toxic for reproduction (CMR)

Substance which is PBT (persistent, bio-accumulative and toxic) or vPvB (very persistent and very bio-accumulative) in accordance with Annex III of REACH

Other substances for which there is evidence of equivalent degree of concern (e.g. endocrine disruptors)

Note that there are over 1000 substances that potentially fulfil these criteria. However, in terms of REACH compliance, SVHC refers specifically to those substances that meet the hazard categories mentioned and that have been placed by the Commission on the Candidate List of substances considered for authorisation.

It is inclusion of substances on the ‘Candidate List’ that triggers additional duties for manufacturers, importers and users. Since 2008, the list has grown steadily through bi-annual updates, at an average rate of 35 substances per year (including substances belonging to specific groups listed as SVHCs).

The European Chemical Agency’s (ECHA) “SVHC Roadmap” states an EU-wide commitment to having “all relevant and currently known SVHCs” on the candidate list by 2020. This could amount to many hundreds of substances.

REACH imposes specific controls on SVHCs over and above those that apply to other chemicals.

What are the obligations?

Communicating information on SVHCs in articles

Any supplier* of an article containing an SVHC on the ‘Candidate List’ in a concentration above 0.1 % (w/w) has the duty to provide the recipient of the article with sufficient information to allow safe use of the article. This information also needs to be provided to consumers within 45 days of a request.

*‘Supplier’ of an article is defined as: any producer or importer of an article, distributor or other actor in the supply chain (e.g. a retailer) placing an article on the market.

Notifying the ECHA of SVHCs in articles

Producers and importers of articles may have to notify the ECHA if their article contains a substance on the Candidate List. This obligation applies if the substance is present above 0.1% (w/w) and its quantities in the produced/imported articles are above 1 tonne in total per year per company. If you import or produce several articles containing the same SVHC, you need to consider the total tonnage, which is calculated by adding the tonnages of the substance for each article that contains the substance at 0.1% (w/w) or higher.

Authorisation

The Candidate List is also the basis for the Authorisation process under REACH. Substances included in the Candidate List will progressively be put forward for inclusion in the Authorisation List (Annex XIV of the REACH Regulation). Substances that will be included in the Authorisation List cannot be manufactured or imported in the EU from a specific date set by the Commission (the ‘sunset date’), except if the companies have obtained an Authorisation for their specific use(s). This Authorisation can either be granted because the risks are controlled or because the socioeconomic benefits outweigh the risks. The aim of Authorisation is to ensure that the risks from substances of very high concern are properly controlled and that these substances are progressively substituted by alternative substances or technologies.

Who is affected and what are the implications?

Any company supplying “articles” is affected by REACH. This includes retailers, manufacturers and distributors of consumer products and suppliers of parts/components to these markets. Examples of markets affected are retail, automotive, electronics, white goods, etc.

The major issue for these “article suppliers” is how to determine whether any of the Candidate List SVHCs are present in their products and at what level. This task is made more difficult by the continuous expansion of the Candidate List. SVHCs have been shown to be contained in a range of consumer products, including shoes, clothing, toys, electronics etc., but manufacturers and retailers are not always aware of their presence. If you want to find out how your products might be affected, and what the likelihood is of them containing any of the current or proposed SVHCs, go to Chemtrac, our in-house developed software tool for regulatory compliance and chemicals management.
The Candidate List

Member States or the Commission can nominate a substance for inclusion in the Candidate List by submitting an Annex XV dossier. After a 45-day consultation period during which interested parties can comment on the dossiers, the proposed SVHCs go through a final procedure whereby the Member States and the Commission decide on whether to include them on the Candidate List. You can find the list of substances that are currently under consultation here.

What is on the horizon?

Before submission of the Annex XV dossier, the substance is notified to the Registry of Intentions in order to give companies advance warning of the possible inclusion of the new substance on the Candidate List.

The list of substances that are currently on the Registry of Intentions can be found here.

Related Links

How can we help?

How to manage your compliance and business risk

To support industry with the effective management of SVHC-related obligations and business risks, as well as a large number of other global chemicals regulations, Yordas has developed Chemtrac, the online tool for chemicals management and regulatory compliance.